1. Field of the Invention
Field of the Invention. This invention relates to surgical devices and procedures, and more particularly for the repair and augmentation of mammalian tissue utilizing a combination of adhesives and prosthetics, such repair, for example treating an inguinal hernia.
2. Prior Art
The surgical repair treatment of inguinal hernias fall into two groups: repairs that involve suturing the prosthesis to the surrounding muscular aponeurotic structures, such as Lichtenstein's operation; and the repairs that involve application of a sutureless prosthesis such as Gilbert's operation.
In the current medical practice, the established procedure in the surgical field is to use mesh, absorbable and non-absorbable, to repair defects in tissue. In inguinal hernia repair Prolene™ mesh and Mersilene™ (manufactured and sold by Ethicon, Inc., Somerville, N.J.) is sometimes used. Marlex™ mesh, an Atlas polypropylene monofilament knit, has also been used. Polypropylene is used because it promotes a fibroblastic response, but this response is only important for ensuring mesh fixation, it is also considered to be too stiff. Knitted and woven fabrics constructed from a variety of synthetic fibers have been used in surgical repair, among other, U.S. Pat. Nos. 3,054,406; 3,124,136; 4,193,137; 4,347,847; 4,452,245; 4,520,821; 4,633,873; 4,652,264; 4,655,221; 4,838,884; 5,002,551; and, European Patent Application No. 334,046.
In mesh applications, generally the mesh is cut to a desired size during the operation. Once the sized mesh has been placed over the defect, the mesh is attached to the surrounding tissue using several known attachment means. The need to shape the mesh during the surgery increases the duration of the surgery and also makes optimal fitting difficult.
The purpose for placing the mesh is: 1) to serve as a barrier over the defect in order to restrict the lower viscera in the patient's abdomen from protruding through the defect. To successfully fulfill the purpose the mesh must be attached with an initial strength of several pounds of force in both the tensile and shear directions. It is also essential that the mesh remain in place for several days so that natural adhesions can form to ensure that the mesh is sufficiently anchored to the tissue.
Commonly mesh is attached to tissue with sutures. Suturing requires a great deal of skill, especially for minimally invasive or laparoscopic procedures. The difficulty in placing sutures is a primary barrier to the general adoption of laparoscopic procedures.
Surgical staplers have been introduced as an alternative to sutures. A surgical stapler such as ENDOSCOPIC MULTI-FIRE STAPLER™, (manufactured and sold by Ethicon Endo-Surgery, Inc., Cincinnati, Ohio) has been used. U.S. Pat. No. 5,470,010 (Rothfuss et al.) discloses a disposable, endoscopic stapler that is used to place a number of staples at various locations of the placed mesh in order to properly secure the mesh.
Both the suture and staple approaches risk a variety of complications. Frequently, because of possible excessive tension and bad distribution of the prosthesis, it isn't able to dynamically suit the modification of relationships among the anatomic structures of the inguinal canal and because it is suture along its periphery. This produces pain that can be felt during movements of the muscular-aponeurotic structures in the inguinal region. The sutures themselves can cause vascular lesions, tissue lacerations, and nerve lesions.
In the prior art, there are also several “sutureless” techniques for inguinal hernia repair. The mesh is applied without suturing by including an underfascial plug placed in the internal inguinal orifice. Plugs however, have their own problems. Perception of an inguinal tumefaction connected to sclerosis stimulated by the presence of the plug is experienced as discomfort by the patient. Displacement of the plug can involve contact of the plug with the extraperitoneal organs and cause possible bedsores on the viscera. Relapses after using the plug are difficult to treat. There is difficulty in treating postoperative suppuaration (formation of pus) because the presence of the underfascial plug cannot be cleaned with superficial dressing. Given the hernia rate in the United States population, the constant use of properitoneal underfascial plugs could cause a significant amount of risk to patients because of possible prosthetic infection if an operation were necessary for a pelvic septic pathology such as tumor of the colon, appendicitis, or surgeries of the prostate and bladder. The plug also tends to displace on the operating table, forcing surgeons to secure the mesh with stitches, thus undermining the sutureless advantage.
Mesh displacement may occur when motion from a supine position to an upright position modifies the reciprocal relationships among the inguinal muscular aponeurotic structures, a sutureless mesh in the upper facial region which is connected to a plug can later displace from the implanted position. The possibility of raising the prosthesis is increased, mainly in the pubis region, which is encountered in the frequent relapses in this area. In the case of the unsutured prosthesis, the fibroplastic reaction is delayed and hindered by the mesh mobility. A cicatricial retraction can ensue acting to additionally deform the mesh. Finally, if the sutureless technique is used in the case of an external oblique inguinal hernia, the yielding of the transversalis layer is coupled with the yielding of the external inguinal ring and of the aponeurosis of the great oblique, said aponeurosis sometimes becomes a fibrous, sliding veil unsuitable to support the prosthesis under abdominal pressure.
U.S. Pat. No. 5,972,007 (Sheffield et al.) discloses an energy-base method applied to prosthetics for repairing tissue defects. The method risks tissue damage from the energy required to be deposited in the tissue to bond collagen pads to living tissue.
An alternative to the mesh is the use of a conical mesh plug which is sometimes placed without attachment. The technique is used in closing abdominal defects, sometimes simply by folding a surgical mesh into a multi-layer cone configuration. Preformed conical mesh plugs have been proposed. C. R. Bard makes a “Marlex Mesh Dart” also known as PerFix®. This implant is heat molded and stiff, and does not conform to irregularities in the muscle or tissue wall defining the defect.
U.S. Pat. No. 5,356,432 (Rutkow et al.) describes an implantable prosthesis including a conical mesh plug having a pleated surface which conforms to the contours of the defect being repaired. Mesh filler is applied to stiffen the implant. However, there is provided no means for fixing the implant position.
With respect to endoscopic techniques, concerns have been raised about visualization light reflected from the fabric surface during laparoscopy, impairing visualization of the prosthetic material and underlying anatomy. Increasing the pore size of the mesh helps, but also diminishes the physical properties of the implant necessary for augmentation or repairing abdominal tissue.
It is an object of the present invention to provide a prosthetic and method for repairing a defect in tissue that is minimally invasive, time and cost effective and easy to use.
It is another object of the present invention to provide a method and prosthetic for facilitating the repair of tissue defects that does not involve sutures, clips, tacks, or staples for stabilization of the prosthetic.
It is another object of the present invention to provide a prosthetic for tissue repair which is characterized by a porosity that allows surgeons to see through the prosthetic during laporoscopy as well as classical open procedures.
It is another object of the invention to provide a prosthetic for tissue repair with a color pattern which facilitates the orientation and/or installation of the mesh at the surgical repair site.
An object of the present invention is the provision of a two-part prosthetic, one side of which prevent or minimizes organ adhesion and surgical adhesive adhesion.
It is thus a primary object of the present invention to overcome the disadvantages of the prior art.
It is another object of the present invention to employ a plug geometry in combination with a surgical adhesive for the repair of hernias including: a plug positionable in an opening in the abdominal wall, a patch positionable over weakened portions of the abdominal part adjacent to the opening, a central extent of the patch being coupled to the proximal end of the plug, and a resilient means coupled to the patch and provided with memory to assume a configuration of an extended shape for the proper positioning of the patch with respect to the weakened portions of the abdominal part.
It is a yet a further object of the present invention to use surgical adhesive in conjunction with a plug to provide bulk to the plug after placement, to provide prosthetic stabilization, and to provide a close fit between plug and surrounding tissue.
It is an additional object of the present invention to provide a prosthetic that can be augmented by the use of a surgical adhesive for the repair of varying sizes and shapes of hernias.
It is yet a still further object of the present invention to disclose a prosthetic combination which lessens or eliminates tractions and tensions inherent to a prosthetic peripherally sutured.
It is another further object of the present invention to provide free and autonomous movement of two prosthetic components.
It is a further object of the present invention to minimize the time, cost and patient discomfort of hernia operations.
It is a further object of the present invention to reduce or preclude the recurrence of hernias.
It is a further object of the present invention to eliminate complication risks associated with the use of staples, sutures or other tissue disruptive means for stabilizing the prosthetic.